(1) Field of the Invention
The present invention relates to liquid human milk supplements for infants.
(2) Description of the Related Art
Preterm or premature infants are categorized as those infants born prior to the 37th week of gestation and/or weighing less than 2,500 grams at birth. Growth rates for preterm infants should ideally meet or exceed age-specific intrauterine growth rates in order to facilitate catch-up growth with term infants. Due to their undeveloped digestive systems and overall developmental immaturity, however, many preterm infants present special nutritional needs.
In general, human milk, because of its nutrient composition and immunological properties, is considered an ideal food for infants. While there are tremendous benefits provided by feeding preterm infants breast milk, their immature digestive systems and limited sucking and swallowing reflexes often prevent preterm infants from consuming adequate amounts of breast milk to satisfy their nutritional needs.
In addition, human milk is typically too low in protein and certain minerals to meet the demands for rapid growth required by many preterm infants. Thus, protein, which is crucial for growth and maintenance of lean body mass, as well as other mediators of biochemical function (e.g. enzymes, immune factors, and some hormones), should be supplemented into the diet of preterm human milk-fed infants. Minerals such as calcium and phosphorus, which are necessary for appropriate bone development and bone density, and vitamins such as, for example, vitamin D should also be supplemented into the diet of a preterm human milk-fed infant.
Furthermore, the energy density of human milk typically requires that preterm infants be fed a volume of milk that is too high to be well-tolerated by the infants. Typically, preterm infants can tolerate total daily feedings of between 100 and 150 ml per kg of the infant's weight. Since the caloric content of human milk is approximately 67 kcal per 100 ml of milk (20 kcal per fluid ounce of milk), and preterm infants require approximately 120 kcal per kg of weight per day, the volume of human milk that can be tolerated by these infants supplies less than 80% of the infants energy needs. Thus, in order to provide a caloric intake that meets the specialized nutritional needs of preterm infants in a volume of milk that the infants can tolerate, the caloric content of the human milk should be additionally supplemented with a source of energy such as fats or carbohydrates.
In addition to these considerations, it is important to provide a human milk supplement or fortifier in which the presence of microorganisms of public health significance and those of non-health significance, yet capable of reproducing in the product under storage and distribution conditions, are reduced or rendered harmless. Thus, it is clear that a need exists for a human milk supplement which can provide the additional calories, protein, vitamins and minerals needed for appropriate preterm nutrition and maintain microbiological quality throughout the shelf-life of the product.